ACTIV-4b

What is the ACTIV-4b Outpatient Study?

ACTIV-4b is a national study to determine if taking an FDA-approved and commonly prescribed blood thinner Eliquis (apixaban), or alternatively, taking baby aspirin is better than taking no blood thinner to prevent blood clots in people with COVID-19 who are recovering from their symptoms at home.

By participating in this study, you will help us learn more about COVID-19 and the best way to treat people newly diagnosed with COVID-19.

HHS; Operation Warp Speed; NIH National Heart, Lung, and Blood Institute; NIH National Institutes of Health Turning Discovery Into Health

What is the link between blood clots and COVID-19?

The chance of blood clots in patients who are diagnosed with COVID-19 is higher than for patients who do not have COVID-19.

To date, doctors can use blood thinner medicines or aspirin to lower the risk of blood clots forming in veins and arteries. Blood clots that form inside the big blood vessels of the legs can travel through the body to the lungs, called pulmonary embolus, which can make it hard to get oxygen.

With COVID-19, blood clots can also form directly in the lungs or in the heart and brain. Blood thinners can be given in different doses to prevent blood clots from forming. Doctors often use lower doses to prevent blood clots from happening and higher doses to treat blood clots that have already happened.

Who is a good fit for the ACTIV-4b study?

Someone who is:

Between 40 - 80 yrs old
COVID-19 positive in the last 14 days and is symptomatic
Not pregnant
Willing to have a blood test to confirm they can safely join the study
Willing and able to take study pills every morning and evening for 45 days
Willing to complete a survey to confirm their study pills were received
Willing to complete 6 weekly check-ins, along with one call 75 days after starting, so study staff can assure safety and track their progress

What happens during the study?

1

While at your local COVID-19 testing site or hospital involved in the ACTIV-4b study, a study team member will determine if you're eligible to participate. They will assist you in signing up.

2

Get your blood drawn at your testing site or with another service.

3

Two days after entering into the study you will receive your study kit, including pills, by mail.

The study team will call you to confirm that you received your package and to answer any questions you may have.

4

Take your study pills, every morning and evening for the next 45 days.

5

Complete 6 weekly follow-ups via text / email or phone call (you choose your preference).

6

Finish taking your pills and complete your week 6 check-in with the study team.

YOU'RE DONE!

After 75 days the study team will make one additional phone call to check-in and see how you're doing.

Which medication is a part of this study?

The ACTIV-4b study is comparing preventative treatments to see if taking an FDA approved and commonly prescribed blood thinner Eliquis (apixaban), or alternatively, taking baby aspirin is better than taking no blood thinner to prevent blood clots in people with COVID-19 who are recovering from their symptoms at home.

Doctors and researchers know these medications work well to prevent blood clots already, but the ACTIV-4b study hopes to find which particular dosage and medication does that best for patients with COVID-19.